Food and Drug Administration
Center for Drug Evaluation and Research
Oncologic Drugs Advisory Committee
73rd Meeting
Holiday Inn
8170 Wisconsin Avenue
Bethesda, Maryland
Agenda
December 17-18, 200212:30 Call to Order and Opening Remarks Donna Przepiorka, M.D., Ph.D.
Chair, ODAC
Introduction of Committee
Conflict of Interest Statement Karen M. Templeton-Somers, Ph.D.
Executive Secretary, ODAC
12:45 Open Public Hearing
BL STN 125011/0, Bexxar®, Tositumomab (Anti-B1) and Iodine131-Tositumomab, Corixa Corporation
- indicated for the treatment of patients with relapsed or refractory low-grade, follicular or transformed low-grade, B-cell non-Hodgkin's lymphoma (NHL) including patients with rituximab refractory follicular non-Hodgkin's lymphoma
1:15 Introduction to Tositumomab Therapeutic Regimen Terrye G. Zaremba, Ph.D.
BLA Committee Chairperson
CBER, FDA
1:30 Sponsor Presentation Corixa Corporation
Disease Outcome and Therapy for Low-Grade Richard Fisher, M.D.
and Transformed NHL University of Rochester
Efficacy and Safety Overview: Basis for Approval Cindy Jacobs, Ph.D., M.D.
Senior Vice-President, Clinical Research
Risk/Benefit Assessment James Armitage, M.D.
University of Nebraska
2:30 Break
2:45 FDA Presentation Center for Biologics Evaluation and Research
Stephen Litwin, M.D.
Medical Reviewer, FDA
3:45 Questions from the Committee
4:15 Open Public Hearing
4:30 Committee Discussion and Vote
ODAC Discussants James Bridges, M.D.
CBER Consultant
James Krook, M.D.
CDER Consultant
5:30 Estimated Time of Adjournment
December 18, 2002
8:00 Call to Order and Opening Remarks Donna Przepiorka, M.D., Ph.D.
Chair, ODAC
Introduction of Committee
Conflict of Interest Statement Karen M. Templeton-Somers, Ph.D.
Executive Secretary, ODAC
8:15 Open Public Hearing
NDA 20-498, S012, CASODEXÒ (150 mg bicalutamide), AstraZeneca Pharmaceuticals LP
8:45 Sponsor Presentation AstraZeneca Pharmaceuticals LP
Introduction and Regulatory History Gerard T. Kennealey, M.D.
Need for CASODEXâ in Early Prostate Cancer Howard I. Scher, M.D.
Memorial Sloan-Kettering Cancer Center
EPC Trial Program: Efficacy and Safety William A. See, M.D.
Medical College of Wisconsin
Relevance to Clinical Practice Mark S. Soloway, M.D.
University of Miami School of Medicine
Summary and Conclusions Gerard T. Kennealey, M.D.
9:45 Break
10:00 FDA Presentation
Background and Review Issues Daniel Shames, M.D.
Director, Division of Reproductive and
Urologic Drug Products, FDA
Medical Review Findings Scott Monroe, M.D.
Medical Reviewer, FDA
Summary and Introduction of Questions Daniel Shames, M.D.
11:00 Questions from the Committee
11:45 Open Public Hearing
12:00 Lunch
1:00 Committee Discussion and Vote
3:00 Estimated Time of Adjournment